Health Trials

A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

ConditionsSolid Tumor, AdultColorectal CancerNon-Small Cell LungNSCLC (Non-small Cell Lung Cancer)CancerColon CancerRectal CancerLung CancerCRCHead and Neck Squamous Cell CancerHNSCCRenal Cell CarcinomaRCCKidney CancerTriple Negative Breast CancerTNBCColorectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorA2 Biotherapeutics Inc.

About this trial

The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression.

The main questions this study aims to answer are:

* Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells

Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:

* Enrollment in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose

Eligibility criteria

Qualifiers

Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A*02 by NGS (whenever possible from the primary site).

Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.

Received previous required therapy for the appropriate solid tumor disease as described in the protocol

Has adequate organ function as described in the protocol

Disqualifiers

Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative

Prior allogeneic stem cell transplant

Prior solid organ transplant

Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion

Trial design

Treatments tested in this trial

  • A2B395
  • xT CDx with HLA-LOH assay

Treatment groups

240 Participants
are divided into 1 treatment group

Sponsors and collaborators

A2 Biotherapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov